Musculoskeletal News Roundup 17-March-17

March 17, 2017
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Blake Mossy

FUNDING

Active Implants secured its first $10 million tranche of a $40 million Class D Units financing led by LS Health Science Partners. The new capital will be used to support Active Implants to support clinical trials of the company's NUsufrace Meniscus Implant, a polymer-based investigational treatment for persistent knee pain following medial meniscus surgery.

Moximed secured $50 million in a Series C round of financing led by newly joined, Advent Life Sciences and Funture fund, and existing investors NEA, Morgenthaler Ventures, Gilde Healthcare, GBS Venture Partners and Vertex Healthcare. The new capital will be used to fund the company through FDA approval and early US commercialization of its products.

M&A

NovoSource is prepared to liquidate its corporate assets through a court-ordered auction in late spring 2017. This will include the company’s knee and hip replacement portfolios, which are for pain reduction and improved function in total knee arthroplasty. The liquidation includes all intellectual property rights, inventory, design history files, trademarks and copyrights, ERP systems and servers, and warehouse equipment and furniture. The value of the inventory and instruments are in excess of $3 million at cost.

REGULATORY

DJO Global received 510(k) clearance from the FDA for its Exprt Revision Hip, a full-line modular femoral stem. The two-tray system is the latest addition to DJO Global’s Exprt portfolio, which defies conventional approaches to total joint implants, represents an 80-90% reduction in instruments compared to competitors and aims to improve price point and minimize operation room time.

First Ray received 510(k) clearance from the FDA for additional sizes and materials in its Stealth Staple System product line, an intraosseous small bone fixation system. The new clearance includes standard sizes in PEEK, small sizes in titanium alloy or PEEK and mini options in titanium alloy. The system is completely contained within bone, which aims to reduce clinical complications related to prominent hardware used in the current standard of care.

Materialise received FDA 510(k) clearance for its Surgicase Orthopaedics system, 3D-printed patient-specific radius and ulna osteotomy guides. The system aims to help surgeons improve planning processes to increase confidence both before and during the surgery that the desired outcome will be obtained.

Medtronic received 510(k) clearance from the FDA for its Kyphone Xpede Bone Cement, indicated for the fixation of pathological fractures of the sacral vertebral body. This covers the expansion of previous indications for treatment of vertebral fractures due to osteoporosis, cancer or lesions.

Spineology received expanded 510(k) clearance from the FDA for its Elite Expandable Interbody Fusion, designed to be implanted into the disc space in a contracted height to minimize dissection and neural retraction, and is incrementally expanded to maximize fit and aims to provide indirect neural decompression. The additional clearance covers a narrower, 10mm, version of the device and an indication to utilize the devices with allograft bone.

PRODUCT INTRODUCTION & UPDATE

Arthrosurface announced the launch of its OVO, a stemless shoulder system indicated for total shoulder arthroplasty. The inlay glenoid shoulder product can be used in all patients in lieu of a standard total shoulder arthroplasty with the advantages of being bone preserving, anatomical, and in appropriately selected patients, able to do as a short stay or same day procedure. The system utilizes a non-spherical humeral head which aims to match the original anatomy more closely than circular head.

Corin launched its Optimized Positioning System (OPS), a technology that aims to allow surgeons to determine optimal implant positioning based on how a patient moves when performing hip replacement surgery. Utilizing pre-operative functional simulation and planning, the system employs 3D printing and laser guidance for implantation.

DePuy Synthes launched its ATTUNE Revision Fixed Bearing Tibial Base and the 14x50 mm Cemented Stem, designed to address a range of patient needs, from complex primary to partial revision of ATTUNE Primary Knees. The system’s fixed bearing base is suitable with fixed bearing posterior stabilized retaining tibial inserts, and utilizes the company LOGICLOCk Tibial Base locking technology, which is designed to enhance kinematics and stability.

DJO Global launched its AltiVate Anatomic Shoulder, a short, bone sparing humeral stem anatomically designed through morphologically-based fit analysis for metaphyseal fit and stability. The device utilizes a glenoid component with the company’s patent-pending “Drop and Go” technology which aims to provide immediate fixation upon implantation.

Ethicon launched its STRATAFIX Knotless Tissue Control Devices and DERMABOND PRINEO Skin Closure System in collaboration with DePuy Synthes. The kits are designed to provide standardization and aim to allow surgeons to choose which sutures they prefer by each layer of closure, and are assembled and supplied by Medical Action Industries, and Owens & Minor Company that manufactures procedure-based kits and trays.

Integra LifeSciences launched its Titan Press-Fit Reverse Shoulder for Fracture, a 2-piece stem design that does not require cement for fixation. The device does not require cement due to its unique two-piece stem that achieves a direct implant-to-bone press-fit fixation below the fracture line in the humeral canal. The design also shows better functional results in fracture scenarios compared to other stem designs.

Paragon 28 launched its Gorilla Calc Fracture Plating System, designed for the treatment of calcaneal fractures. The system includes 20 titanium low-profile lateral extensile approach plates and sinus tarsi approach plates which can be contoured intraoperatively to the surgeon’s preference.

Stryker launched its Mako System, a robotic-arm assisted technology for joint replacement service line to perform total knee, total hip and partial knee replacements. Utilizing the company’s Triathlon Total Knee and CT-based 3d modeling of bone anatomy, surgeons can us the system to create patient specific surgical plans and identify the implant size, orientation and alignment.

Stryker Instruments launched its System 8 power tools, a system providing improved ergonomics and higher-capacity battery cells. The company also introduced its EZout Powered Acetabular Revision System, a power tool system indicated for hip revision surgeries that aims to allow surgeons to consistently remove an acetabular cup in a short period of time and improve results compared to manual cup revision tools. The system 8 portfolio includes: System 8 cordless driver, System 8 SABO Sagittal Saw and Styker Precision Saw. The platform will be able to connect to Smart Equipment Management (SEM), an online data module to help manage the company’s smart devices through device-derived data.

Zimmer Biomet announced the launch of its Signature Solutions, a portfolio of clinical services and technologies. These solutions are designed to assist care providers during the transition to value-based healthcare models.

REIMBURSMENT

Medovex Corp received a renewed reimbursement payment coding from the German Reimbursement Authority for its DenerveX System technology designed to provide longer lasting pain relief associated with facet joint. The new coding allows for healthcare providers to receive reimbursement for the use of the system while treating Facet Joint Syndrome in the spine.

CLINICAL

OMNIlife science announced the first clinical use of novel robotic tissue balancing with its OMNIBotics robotic-assisted total knee replacement platform. The system enables knee implant placement using robotics driven by the company’s ART software, providing patient-specific procedures, eliminating the need for preoperative CT scans or x-rays and allows for intraoperative adjustments and precise alignment.

Spine Innovation announced the first implantations of its Expandable TLIF device. The device is inserted on its side to reduce the risk of neural injury, and is rotated 90 degrees to restore disc height up to 16mm and lordosis up to 15 degrees. The implant is then expanded 10mm laterally to create and implant width of up to 22mm with a large graft area that is accessible by the surgeon for the implantation of bone graft in the device.

DISTRIBUTION

BONESUPPORT announced the extension of its distribution agreement with Zimmer Biomet. Under the terms of the agreement, Zimmer Biomet will continue to have exclusive rights for BONESUPPORT’s proprietary CERAMENT BONE VOID FILLER product line, intended for orthopedics, trauma and foot and ankle indications in the U.S. The company is also enrolling patients into its FORTIFY Clinical Study for its CERAMENT G antibiotic eluting product.

Implanet announced the integration of Jazz Claw into the Australian Register of Therapeutic Goods and entered into an exclusive distribution agreement with Device Technologies for product distribution in Australia and New Zealand. The Jazz Claw aims to provide autostable posterior fixation by replacing traditional hook-and-screw fixation systems.

INTELLECTUAL PROPERTY

Amend Surgical entered into an agreement with The University of Florida Research Foundation (UFRF) to license patents for the development of Biomimetic Bone, an artificial bone substitute. University of Florida researchers have developed a process for mineralizing collagen substrates using a polymer-induced, liquid-precursor process, generating an artificial bone substitute that mimics the composition and structure of natural bone. This process will allow Amend to fabricate a highly mineralized, load-bearing, bioresorbable, collagen hydroxyapatite composite technology.

APPOINTMENTS

HealthpointCapital appointed Mike Mogul as Managing Director. Mr. Mogul was most recently President, Chief Executive Officer and Director of Blackstone-owned DJO Global. Under his leadership, DJO, a $1 billion firm in the Orthopedic sector, was market leader in both share and growth in non-operative orthopedic medical devices including Bracing and Physical Therapy equipment, and was also the fastest growing manufacturer of Total Joint implants and Consumer Sports Medicine products. Prior to joining DJO, he served as Group President, Orthopaedics for Stryker Corporation where he ran Stryker’s global orthopedic businesses. Mr. Mogul will join the experienced team at HealthpointCapital, led by John Foster, Chairman. Foster is a leader in healthcare private equity investing with over 37 years of experience, including nine previous PE funds.